ISO 10005:2018 Published

In 2018, ISO published the third edition of the standard on quality plans, ISO 10005:2018 Quality Management – Guidelines for quality plans. The new standard has the following major sections:

Using a quality plan

Development of a quality plan

Content of the quality plan

Operation and control of the quality plan

It also has two useful annexes:

Annex A Examples of formats for quality plans

The examples are:

A “text” type of quality plan

A “table” type of quality plan

A “Flow chart” type of quality plan

Annex B Schematic representation of a process approach applied to quality plans

This includes a diagram that is a variation of the SIPOC diagram.

EMC Directive Harmonized Standards

In 2018 the current version of the EMC Directive, 2014/30/EU, replaced the original version, 2004/108/EC. On July 13, 2018 the EU issued a list of harmonized standards to the current version. See

The standards bodies are CEN (, CENELEC (, and ETSI (

Auditing Standard Updated

ISO has issued ISO 19011:2018 Guidelines for Auditing Management Systems. The standard provides guidance on auditing management systems in general. It does not focus on any particular management system, meaning it could equally apply to ISO 13485:2016 or FDA’s QSR. The standard’s guidance on auditing management systems includes:

  • The principles of auditing
  • Managing an audit program
  • Conducting management system audits
  • Evaluating competence of people involved in the audit program
FDA Transition to ISO 13485:2016

In Spring 2018, FDA announced it intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016.


At a recent MDSAP meeting FDA provided an update on its intention.

FDA estimates it will issue the proposed rule in the Fall 2019.

FDA recognizes the significant impact for implementation. For example:

  • Training on ISO 13485 requirements, interpretation, best practices, etc. to CDRH staff and ORA investigators and compliance officers
  • Changes to the inspection model (QSIT)
  • Revisions/updates to numerous documents
  • Changes to IT systems

FDA suggests the transition period will likely be a few years.

Article on Demonstration Tests added to the Ombu Library

The Ombu library, in the Data Analysis aisle, has an article about determining the sample size when each item is either conforming or nonconforming. The article explains the use of the binomial distribution. It also covers the special case of the sample size when based on a confidence level and process nonconformance rate.